Valve with smart handle

ABSTRACT

A valve with a smart handle including a memory module to log relevant data. A sensor on the handle determines when the valve is open, and this triggers the start of timers and recording of the “open” event in a log in the memory module. When the valve is closed, the sensor triggers stopping of the timers and recording of the “closed” event in the log. The timer information is used to calculate the duration of the time “open” event, and this, together with the actual date and time of the opening and closing of the valve are recorded in the log. Other relevant information, such as cylinder fill date, cylinder I.D. number, batch number, and patient name or account number may also be logged in the memory module. The log of the events and the corresponding dates and times may be used to prepare invoices for billing gas treatments, for inventory control, and for other record-keeping and control functions.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to valves and, in particular, to avalve with a special handle that tracks the usage of the valve to enablelogging and billing. The valve handle may thus be used not only todispense a gas but, in combination with the disclosed procedure, toprovide a method for conveniently providing tracking of the use of thegas and subsequent billing for medical treatments using the gas.

[0002] Some medical treatments involve the use of gases that are inhaledby the patient. In the past, medical gas suppliers have charged for thegas in the cylinder at the time of delivering the filled cylinder to theuser. This method has been used both for industrial and medical uses.Pharmaceutical gases, dispensed by prescription, have great variabilityof use from patient to patient due to treatment regimen and dispensingmethods. A method of charging for treatment time would be a desirableway for allocating the true value of the product. However, in the past,there has not been a way to automatically track the duration oftreatments by cylinder or to tie the treatments to the patients whoreceive the treatments in order to make it easy to bill for use of thegas. Such a method is provided in accordance with the present invention.

SUMMARY OF THE INVENTION

[0003] The present invention provides a valve with a smart handle forthe gas bottle (or cylinder). This valve records all the treatmentinformation and makes the information readily accessible for use intracking and invoicing. It permits the vendor to invoice the user fortotal treatment time and to provide users, such as hospitals or clinics,the information to bill individual patients. It also provides both thevendor and the user with data which is useful for trend analysis andinventory control.

[0004] The valve handle includes sensors for sensing the opening andclosing of the valve, a timer for timing the duration over which thevalve is opened, and an electronic memory device which records thepertinent information. The information recorded by the memory device mayinclude the cylinder fill date, the lot batch number, cylinder number,the patient's name, the number of times the valve is opened, and thedate, time, and duration of each opening of the valve, as well asadditional information, if desired.

[0005] The data then can be readily transferred from the memory deviceto a device that generates reports or invoices.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006]FIG. 1 is an exploded, perspective view of an example of a valvewith a smart handle made in accordance with the present invention;

[0007]FIG. 1A is the same view as FIG. 1 but from a differentperspective and with the lock mechanism further exploded from the view;

[0008]FIG. 2 is the same view as FIG. 1 but from a differentperspective;

[0009]FIG. 2A is the same view as FIG. 1 but with the lock mechanismfurther exploded from the view,

[0010]FIG. 2B is a schematic diagram showing the processor mounted onthe handle of FIG. 1 and the input/output devices associated with it;

[0011]FIG. 3 is a side view of the valve of FIG. 1 mounted on a gascylinder;

[0012]FIG. 4 is an enlarged plan view of the valve and cylinder of FIG.3;

[0013]FIG. 5 is an exploded, perspective view of the handle part of thevalve of FIG. 1;

[0014]FIG. 6 is an enlarged bottom view of the assembled handle of FIG.5;

[0015]FIG. 7 is an enlarged side view of the assembled handle of FIG. 5;

[0016]FIG. 8 is a section view taken along the line 8-8 of FIG. 7;

[0017]FIG. 9 is a schematic operational logic diagram for the valvehandle of FIG. 1;

[0018]FIG. 10 is a perspective view of the handle of the valve of FIG.1;

[0019]FIG. 11 is a perspective view of a hand-held recorder used toexport data from the valve of FIG. 1;

[0020]FIG. 12 is a perspective view of a button-type storage device usedwith the recorder of FIG. 11;

[0021]FIG. 13 is a hand-held portable computer which may be used toinitialize the memory device on the valve of FIG. 1, and which may beused to export data from the memory device;

[0022]FIG. 14 is a wand reader used to transfer data to and from thevalve handle of FIG. 1 and to and from a computer;

[0023]FIG. 15 is a perspective view of a BlueDot receptor that may beused for transferring data from a button-type memory module (as shown inFIG. 12) to a computer; and

[0024]FIG. 16 is an adapter which can be used to download data from thevalve of FIG. 1 to a button-type memory module.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0025] FIGS. 1-16 show a first preferred embodiment of the presentinvention. A valve 10 is provided, which may be attached onto a gascylinder 12. The cylinder may contain pharmaceutical gas or other gases.

[0026] Referring to FIGS. 1, 2, and 3, the valve 10 includes a valvebody 14, a stem 15 projecting upwardly from the valve body 14, and ahandle 16 mounted on top of the valve stem 15 for manually opening andclosing the valve 10. FIGS. 1 and 2 show that the valve body 14 includesa threaded inlet port 18 which screws onto the outlet port of thecylinder 12. The valve body 14 also includes an outlet port 20. Thevalve body 14, the outlet port 20, and the inlet port 18 may be modifiedfor specific uses, cylinder sizes, or gases.

[0027] The handle 16 mounts on the valve stem 15. An operator grasps thehandle 16 and rotates it in order to open and close the flow of gas fromthe cylinder 12 to a ventilator or other gas dispensing device (notshown). The handle 16 has a substantially circular cross-section andincludes ribs around its outer edge to facilitate grasping the handle.

[0028] As shown in FIG. 2B, several electronic devices are mounted inthe handle, including a processor 23, a timer 21, a reset button 27, anopen/closed sensor 28, a battery 25, a display 26, and an electronicmemory device 22. In this embodiment, the memory device 22 communicateswith a one-wire port 22′ that projects to the exterior of the handle 16.The one-wire port 22′ in this embodiment is a metal can, which has thesame shape as the portable memory buttons 22A, shown in FIG. 12, thatcan be used to transfer data from the handle's memory 22 to otherdevices. This enables the same communication devices to be used with theport 22′ and with the memory buttons 22A.

[0029] Most of the components of FIG. 2B are housed inside a compartmentformed by the handle 16 and the cover 24 in this preferred embodiment.The processor 23 is located inside the handle cover 24 and communicateswith the electronic memory device 22. Also inside the handle cover 24are two (2) small batteries 25. While FIG. 2B shows a single timer 21,there preferably are at least two timers 21, one of which is a calendar,and the other of which is an event timer. The reset button 27, locatedinside the handle 16, may be depressed to reset the event timer 21. Atleast a portion of the top surface of the handle cover 24 is clear, inorder to permit the user to view the LCD display 26 mounted inside thehandle 16. On the underside of the handle 16 is mounted the sensor 28,as seen in FIGS. 1A, 2 and 8. The sensor 28 that is used in thispreferred embodiment is a proximity switch model MK20-BV50:170manufactured by Meder Inc. A collar 30 is mounted onto the valve body14, just below the handle 16. This collar 30 holds a stationary magnet32 (See FIG. 1). In the embodiment shown here, the collar 30 has atwenty-four-sided interior cross section 34 which fits directly onto thenut 36 on the valve body 14, so the collar 30 remains stationaryrelative to the valve body as the handle 16 is rotated to rotate thevalve stem 15, in order to open and close the valve. The angularposition of the collar 30 may be changed by lifting it up and rotatingit, then fitting it back down over the nut 36. However, this can be doneonly when the handle 16 is removed from the valve 10.

[0030] The handle 16 is protected from undesired removal by a specialstud 38 (such as a “Torx” stud) and its corresponding security nut 39(See FIG. 5), making it difficult for anyone to tamper with the positionof the collar 30 and magnet 32, as will be explained in detail later.The proximity sensor 28 is mounted on the handle 16, and the collar 30is positioned so that, when the handle 16 is rotated to the closedposition, the sensor 28 is adjacent to the magnet 32 that is fixed tothe collar 30. When the proximity sensor 28 is adjacent to the magnet32, it sends no signal to the processor 23, thereby indicating that thevalve is in the “closed” position. When the handle 16 is rotated to openthe valve, the proximity sensor 28 senses that it has been moved awayfrom the magnet and sends a signal to the processor 23, indicating an“open” position. The processor 23 instructs the memory 22 to record theevent of opening the valve and to record the time and date of the eventas indicated by the calendar timer 2:1. The processor 23 instructs thememory device 22 to continue checking the position of the valve as longas the valve 10 is open. When the valve is closed, the processor usesthe logged open and close times to calculate the amount of time thevalve was open and instructs the memory device 22 to record thatduration as well a recording an accumulated open time duration. Thus,every time the valve 10 is opened, the time and date of the event isrecorded, the closing time and date is recorded, the duration of timeduring which the valve 10 is open is calculated and logged, and theaccumulated open time is calculated and logged. FIG. 9 shows theoperational logic for the timing and logging operation.

[0031] While the simple proximity sensor 28 and magnet 32 are used inthis preferred embodiment, many other arrangements are known in the artfor sensing and signaling when the valve 10 is open and when it isclosed, and it would be obvious to those skilled in the art to use otherknown sensing arrangements.

[0032] The display 26 may be arranged to display in a variety of ways.However, in this embodiment, it alternates flashing of two differentnumbers—first the accumulated open time, and then the open time for thecurrent event preceded by a “plus sign”. If the valve is closed, thenthe current event open time flashes as a “minus sign” with no digitsadjacent to the “minus sign”.

[0033] The threaded security stud 38 is fixed at its top end to thehandle cover 24 and projects downwardly. It is received by the specialsecurity nut 39, which is rotatable relative to the handle 16 but istrapped onto the underside of the handle 16. The nut 39 must beunthreaded from the stud 38 in order to remove the handle cover 24 toallow access to the interior of the handle 16. This arrangement helpsmake the handle 16 tamper-proof. Once the handle cover 24 has beenremoved, there is access to the batteries 25, reset button 27, and soforth, and there is access to the screw 37 which secures the handle 16to the valve stem 15.

[0034] An optional locking device 54 (See FIGS. 1A and 2A) preventsinadvertent rotation of the handle 16 during transport and can only beinstalled when the valve handle 16 is in the closed position. Thisserves to provide additional visual cues of the valve handle 16 positionto the user. The locking device 54 preferably is made of plastic andincludes a curved wall 56, which conforms closely to the shape of theoutside wall of the valve handle 16. An arm 58 extends inwardly from thelower end of the wall 56, and a finger 60 projects upwardly from thefree end of the arm 56. The finger 60 is designed to mate with the holeof the security nut 39, while the arm 58 fits snugly within the notch 40of the fixed collar 30. A tab 62 at the top end of the locking device 56projects both outwardly and inwardly, so that, when installed, theinward portion of the tab 62 snaps over the top of the handle 16 toretain the locking device 56 in place on the handle 16, with the finger60 mated to the security nut 39 and the arm 58 in the notch 40 of thecollar 30.

[0035] Since the collar 30 is fixed on the valve 14, and the arm 58 ofthe locking device 54 is caught in the notch 40 of the collar 30, thelocking device 54 is fixed and does not rotate relative to the valvebody 14. Furthermore, since the finger 60 is attached to the arm 58(which is part of the locking device 54), and is mated to the securitynut 39 (which is part of the handle 16), then the handle :16 is alsounable to rotate relative to the valve body 14. In order to open thevalve 10, the locking device 54 is removed by pushing downwardly on theoutwardly-projecting portion of the tab 62 to release theinwardly-projecting portion of the tab 62 from the top of the handle 16,and then the locking device 54 is slid downwardly to remove the finger60 from the nut 39 and to remove the arm 58 from the notch 40. Then, thehandle 16 can be rotated to open the valve 10. As long as the lockingdevice 54 is properly attached to the valve 10, accidental opening ofthe valve 10 (such as due to vibration during transport) is unlikely.

[0036] Installation of the Valve and Handle:

[0037] The following steps may be taken to install the valve and handleon the gas cylinder. First, the valve body 14 (without the valve handle16) is installed onto the cylinder 12 by threading the inlet port 18 ofthe valve body onto the cylinder 12. At this point, the valve stem 15 isin the full clockwise (closed) position. The cover 24 is removed fromthe handle 16, and the handle 16 is temporarily placed onto the valvestem 15 by placing the square hole 15A of the handle 16 over the valvestem 15. The handle 16 should be in a position in which there will beeasy access to the memory module 22. The location of the security nut 39should be noted, and then the handle 16 should be removed from the valvestem 15.

[0038] As shown in FIGS. 2 and 6, the collar 30 has a notch 40, whichshould only line up with the security nut 39 when the valve handle 16 isin the closed position, so the only time there will be access to thesecurity nut 39 will be when the valve is closed. This will ensure thatthe handle 16 may only be removed when the valve 10 is closed. Thetarget collar 30 should be installed over the nut 36 with the notch 40in the proper position to provide access to the security nut 39 when thevalve is closed. The position of the notch 40 may be adjusted by liftingthe collar 30 off of the nut 36, rotating the collar 30, and thenreinstalling the collar 30 on the nut 36 until the notch 40 on thecollar 30 matches up with the intended location of the security nut 39.The 24-point cross-section 34 of the collar 30 allows for precisepositioning of the collar 30 on the hexagonal nut 36.

[0039] Once the collar 30 and its notch 40 and magnet 32 are properlypositioned onto the valve body 14, the handle 16 can then be placed backonto the valve stem 15, with the square opening 15A of the handle 16fitting onto the valve stem 15, making sure to align the security nut 39with the notch 40 on the collar 30. The handle 16 is then secured to thestem 15 by using a Fender washer 35 and threading a button-head capscrew 37 from the top side of the handle 16 into the threaded top of thestem 15, as is well known in the art. (See FIG. 1).

[0040] The reset button 27 on the inside of the handle 16 is thendepressed to reset the timers 21. The handle cover 24 is then installedonto the handle 16 by lining up the security stud 38 with the securitynut 39 and tightening the security nut 39 from below, extending a toolupwardly through the notch 40. This draws the handle cover 24 onto thehandle 16. The LCD display 26 should read -00.0 The minus sign indicatesthat the valve handle is not currently logging time and ensures that themagnet 32 on the target collar 30 and the sensor 28 on the handle 16 areproperly aligned. When the valve handle 16 is in the closed position,the LCD display 26 toggles between a “----” display indicating that thevalve 10 is closed, to a “-XXX” display where XXX represents the totalaccumulated time the cylinder has been open. When the valve handle 16 isin the open position, the LCD display 26 toggles between the treatmenttime display and the total accumulated time display.

[0041] Configuring the Valve with Smart Handle

[0042] Once the valve handle 16 is reset and is mounted on the cylinder12, the valve handle should now be configured to input the initialparameters such as:

[0043] Born on date (date when cylinder was filled)

[0044] Cylinder serial number

[0045] Gas lot number

[0046] Set the timers (which may include a calendar timer and an eventtimer)

[0047] Clear the log registers

[0048] Additional area may be available for recording specific notes orinformation relative to a specific treatment or lot.

[0049] This initial configuration would typically be done by thedistributor who is filling and supplying the filled cylinders to theuser. The distributor uses a computer in which the required software hasbeen previously installed and the initialization parameters have beenpreviously inputted. The distributor inputs the initializationparameters from its computer to the smart handle 16 by some known datatransfer mechanism. In this preferred embodiment, the distributor usesthe transfer device 44 shown in FIG. 14. This transfer device plugs intothe distributor's computer at one end, and the other end fits onto theone-wire port 22′ on the handle 16 to transfer the initializationparameter data from the distributor's computer to the memory 22 in thevalve handle 16.

[0050] Similarly, the user (such as the hospital) may add more data intothe memory device 22 of the valve 10. This information may include apatient identification number, a treatment number, and so forth, whichthe hospital may use for its record keeping and for billing its patientsor other end users. One way to add that data is by using a hand heldcomputer 50 or laptop (not shown), inputting the information into thecomputer 50 and transferring that information to the memory device 22through an adapter 48 (shown in FIG. 16) and through the transfer device44.

[0051] The hospital or other user, as well as the distributor, may laterdownload the data from the memory device 22 to be used for recordkeeping and billing.

[0052] Valve Operation

[0053] Typically, the outlet port 20 of the valve 10 is connected to adelivery device, such as a ventilator (not shown), which is used toadjust the concentration and flow rate or to mix gases administered tothe patient. When the valve handle 16 is turned to open or close thevalve, the proximity sensor 28 triggers the processor 23 to instruct thememory device 22 to log the event, including date, time, and whether theevent was an opening or a closing of the valve. This information isstored in a non-volatile, read-only-memory (NVROM) in the memory device22. As was explained above, FIG. 9 shows a schematic operational logicdiagram for the timer of the valve 10. Thus, as the handle 16 is rotatedto open the valve 10 in order to provide gas treatments to patients, thememory device 22 in the handle :16 records the number and duration ofthe treatments.

[0054] All this information may be read or downloaded by the user and/orby the supplier, using a number of data transfer methods. Three methodsare described here, but others may also be used.

[0055] 1—Using a PIR-2 reader (See FIG. 11), the information may bedownloaded into portable DS-1996 iButtons 22A (See FIG. 12). Eachportable iButton 22A has enough memory to store the data for 12 valves,with each valve having up to 72 logs.

[0056] The data on the portable iButtons 22A may then be transferred toa computer via a DS-1402 BlueDot receptor 52 (See FIG. 15). The data maybe imported into a suitable software program, such as a spread sheetprogram, to generate usage reports or billing reports.

[0057] 2—The data may be downloaded directly onto a hand-held or lap-topcomputer 50 using a wand reader 44, as shown in FIG. 14, whichcommunicates through the one-wire port 22′, and then it may bedownloaded from the portable computer 50 to a main computer. Dependingupon the types of ports on the computer, an adapter 48, as shown in FIG.16 may be used. Again, the data may be imported into a suitable softwareprogram to generate usage reports or billing reports.

[0058] 3—The data may be sent directly from the port 22′ on the handle16 to a printer.

[0059] The user may use the generated reports to keep a record of thetreatments on the patients, for record keeping, for billing thepatients, and for checking the billing it receives from its supplier.The supplier may use the generated reports or print outs to bill theuser for the treatments and for inventory control purposes.

[0060] For instance, a worker may walk around the user's facility (ahospital or clinic, for example) at certain intervals with a readingdevice and download the data from the ports 22′ on the handles 16 of thecylinders 12 to a portable iButton 22A or to some other portablerecording device. It would also be possible for the handle 16 to includea transmitter to transmit the data to a remote recording device atintervals or on command, as desired. The HA7MB reader of FIG. 16(produced by Point Six, Inc. of 391 Codell Dr., Lexington, Ky. 40509,USA) may be used to transfer data from the memory device 22 to portableiButtons 22A using a handheld computer 50. The collected data on theiButtons 22A is then downloaded into a main computer. The software inthe computer then uses the data that has been collected to generatereports, to track treatments, do billings, and to control inventory.While this method of moving data from the valve handle 16 to thecomputer station is preferred, it is understood that many other methodsfor transmitting the data from the valve 10 to the main computer couldbe used.

[0061] In the first preferred embodiment shown in FIGS. 1-16, a DallasSemiconductor 1-wire protocol establishes a method for storing andretrieving information from the handle.

[0062] Some advantages of this Smart Valve handle system include:

[0063] The system provides a convenient way to track and charge fortherapy, as the gas is being used, instead of just charging for a bottleof gas. This may be much more desirable for the parties.

[0064] Actual treatment time can be ascertained directly at the gascylinder, and the smart valve 10 is relatively tamper proof, so there islittle opportunity for error or fraud.

[0065] Little or no paperwork is required, as all the data is stored inelectronic format.

[0066] The data may be stored as a comma delimited file, making it easyto import the data into spreadsheet or database software (such asAccess™ or Excel™) for data servicing and manipulation.

[0067] Data logs are also maintained in the Smart Handle device allowingfor a back-up of the downloaded material.

[0068] The record of the Born On Date (date the cylinder is filled) andBatch number reside at the bottle in the memory device 22. It is notnecessary to search this data in files from a serial number or bar code.

[0069] The system allows for expansion and software development whichwill provide hospitals and researchers the ability to track trends inpatient use of various treatments, develop therapy protocols, assignpatient ID to cylinders, identify and control cylinders for blindedclinical trials, and other uses currently handled by means ofcomplicated and labor-intensive administrative methods.

[0070] Various password protections may be used to ensure that only theappropriate users can make certain inputs of data. For example, only theenterprise filling the cylinders should be able to input the Born OnDate.

[0071] The embodiment described above is only intended to be one exampleof a device made in accordance with the present invention. It will beobvious to those skilled in the art that modifications may be made tothe preferred embodiment described above without departing from thescope of the present invention.

What is claimed is:
 1. A valve handle for mounting on a valve stem toopen and close a valve, comprising: a valve handle body, defining areceptacle for receiving the valve stem; a sensor on said valve handlebody, for sensing the opening and closing of the valve; a timer on saidvalve handle body; and an electronic storage device mounted on saidvalve handle body, in communication with said sensor and said timer,wherein said storage device records the date and time of opening andclosing of the valve and the duration of time that said valve is open.2. A valve handle for mounting on a valve stem to open and close a valveas recited in claim 1, wherein said timer includes a calendar timer andan event timer.
 3. A valve handle for mounting on a valve stem to openand close a valve as recited in claim 2, and further comprising anelectronic data input means in communication with said storage device,for permitting a user to enter additional data to be stored with saiddate and time.
 4. A valve handle for mounting on a valve stem to openand close a valve as recited in claim 1, wherein said sensor includes aproximity switch.
 5. A valve handle for mounting on a valve stem to openand close a valve as recited in claim 4, and further comprising dataoutput means for downloading data from said electronic storage device.6. A valve with a smart handle, comprising: a valve body for controllingthe dispensing of fluid through said valve; a valve stem projecting fromsaid valve body; a valve handle mounted on said valve stem for openingand closing said valve; a sensor on said valve handle, which senses theopening and closing of said valve; a timer on said valve handle; and anelectronic storage device mounted on said valve handle, in communicationwith said sensor and said timer, wherein said storage device records theopening and closing of said valve and the time of said opening andclosing events.
 7. A valve with a smart handle as recited in claim 6,and further comprising a port in communication with said storage device,permitting a user to enter additional data to be stored by saidelectronic storage device.
 8. A valve with a smart handle as recited inclaim 6, wherein said sensor includes a proximity switch.
 9. A valvewith a smart handle as recited in claim 8, and further comprising atarget collar mounted on said valve body, said collar including a magnetwhich triggers said proximity switch.
 10. A valve with a smart handle asrecited in claim 9, wherein said target collar defines a notch to allowaccess into said valve handle only when said valve is in a closedposition.
 11. A valve with a smart handle as recited in claim 10, andfurther comprising a handle cover and a fastener which secures saidhandle cover onto said handle, wherein access to said fastener isthrough said notch.
 12. A valve with a smart handle as recited in claim11, and further comprising data output means for downloading data fromsaid electronic storage device.
 13. A valve with a smart handle asrecited in claim 12, and further comprising a locking device whichprevents relative motion of said handle relative to said collar.
 14. Avalve with a smart handle as recited in claim 13, wherein said lockingdevice includes an arm which engages said notch in said target collar,and a projection which engages said handle.
 15. A method for trackingthe use of gas for medical treatments, comprising the steps of: moving ahandle to open a valve; sensing the opening of said valve;electronically recording onto a memory device as data the opening of thevalve and the time the valve was opened; moving said handle to closesaid valve; sensing the closing of said valve by a sensing means, andelectronically recording onto a memory device as data the closing of thevalve and the time the valve was closed; calculating from said times aduration of time that said valve was open and electronically recordingthat duration as data.
 16. A method for tracking the use of gas formedical treatments as recited in claim 15, wherein the sensing means andthe recording device are located on the handle.
 17. A method fortracking the use of gas for medical treatments as recited in claim 16,and further comprising the step of inputting and recording onto thememory device patient identification information.
 18. A method fortracking the use of gas for medical treatments as recited in claim 17,and further comprising the steps of: importing said recorded data andpatient identification information from said memory device into acomputer; and using said imported data to create a billing invoice.